Skip to main content

Author name: contact@devinevisiontech.com

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06103 Pharmaceutical Production

SOP on SOPs (SOP on Standard Operating Procedures) – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103 SOP on SOPs (SOP on Standard Operating Procedures) Pharmaceutical Production • Source Session/Topic 5 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 5: SOP on SOPs (SOP on Standard Operating Procedures) Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Define SOP of SOPs • Explain the components of SOP of SOPs • Develop an SOP of SOPs Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer • Handout 5.1: Format for SOP of SOPs SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |05 minutes |Presentation |Definition | |3 |10 minutes |Presentation |Components of SOP of SOPs | |4 | |Small group |Development of SOP of SOPs | | |90 Minutes |activity | | | | |Presentation | | |5 |05 minutes |Presentation |Key Points | |6 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: SOP of SOPs (5 minutes) • In order to write Standard Operating Procedure, another Standard Operating Procedure is needed to standardize and guide the process • The SOP that guides how other SOPs in the organization should be prepared is known as an SOP of SOPs or a mother SOP STEP 3: Components of SOP of SOPs (10 minutes) • Components of the SOP of SOPs; o Purpose ▪ The purpose of SOP of SOPs is to describe procedures for preparation, review and approval of standard operating procedures in pharmaceutical production o Scope ▪ This part of the SOP of SOPs describes the way the SOP of SOPs applies to all SOPs o Responsibility ▪ This part identifies people (Executive/QA officers or other designated persons) responsible for preparation, revision, periodical review and approval of the SOP of SOPs ▪ Persons responsible for the preparation, revision and periodic review of the SOP of SOPS ▪ Person(s) responsible for review and training of the SOP of SOPs ▪ Person(s) responsible for approval of the mother SOP o Procedure ▪ This part should, ▪ Specify the format of all SOPs in the organization ▪ Specify paging and placement of company logo on SOPs ▪ Specify header, content and footer of the SOPs ▪ Specify font style, font size and line spacing in all SOPs ▪ Specify numbering system (and description of characters used in the numbering system) for the SOPs ▪ Specify placement of dates (supersedes, approval date, effective date and review date) for SOPs ▪ Specify the signatories of various SOPs in the organization (i.e. prepared by, reviewed by, approved by) ▪ Specify the content of SOPs ▪ Purpose, scope, responsibility, procedure, revision, abbreviations, annexures, header, footer, as described in session 7) o Revision ▪ Describes revision of SOPs ▪ Provides a revision log showing revision number, effective date and reason for the revision of each SOP revised o Abbreviations ▪ Should show abbreviations or acronyms used in the mother SOP and their expanded form o Annexure ▪ Provides a list of all the annexure used in the mother SOP (e.g. SOPs format, list of codes) STEP 5: Developing an SOP of SOPs (90 minutes) [pic][pic] Refer students to Handout 5.1: Format for SOP of SOPs |Activity: Small Group Assignment (60 minutes) | | | |DIVIDE students in manageable groups | | | |ASK the students to work on the following assignment | | | |Prepare an SOP of SOPs for a Compounding Laboratory in your school | | | |ALLOCATE time for students to do the assignment and presentation | | | |REFER students to recommended references | STEP 6: Key Points (5 minutes) • SOP on SOPs is the standard operating procedure for preparation of all SOPs in an organization • It guides the process of preparing SOPs in all departments of an organization • SOP of SOPs is also known as the mother SOP STEP 7: Evaluation (5 minutes) • What is an SOP? • What is SOP of SOPs? • Mention the components of an SOP of SOPs • Who is responsible for preparing the SOP of SOPs in a pharmaceutical manufacturing company? References Escope, Adriene, (1997). Nimble documentation, the practical guide for World class organization, Milwaukee, Wisconsin, American Society for Quality, Quality Press Garner, Willa Y and Mureen S. Barge, Editors, “Good Laboratory Practices. An agrochemical perspective” ACS Symposium Series 369, American Chemical Society Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press, Colorado. Shayne C et al (2008), Pharmaceutical Manufacturing Handbook: Production and processes, John Wiley & Sons |[pic] |Handout 5.1: General Format for SOP of SOPs | | SOP ON STANDARD OPERATING PROCEDURES | |Title: |Copy no.: | |Organization/Company: |Page no.: | |SOP of SOPs No.: |Supersedes: | | |Effective date: | |Review Date: |Prepared By |Reviewed By |Approved By | |Designation | | | | |Signature and Date | | | | 8. Purpose 9. Scope 10. Responsibility 11. Procedure 12. Revision 13. Abbreviations 14. Annexures ← Previous TopicNext Topic →View all Pharmaceutical Production topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06103 Pharmaceutical Production

Standard Operating Procedure (SOP) – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103 Standard Operating Procedure (SOP) Pharmaceutical Production • Source Session/Topic 4 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 4: Standard Operating Procedure (SOP) Total Session Time: 120 minutes + 240 minutes of Assignment Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Define standard operating procedure (SOP) • Explain the importance of SOP • Outline types of SOPs • Explain the components of SOP • Explain the development and approval processes of SOP Resources Needed • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer • Handout 4.1: Sample format for Writing SOP • Handout 4.2: Sample Guide for Writing Procedure Part of SOP SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |20 minutes |Presentation |Definitions | |3 |10 minutes |Presentation |Importance of SOPs | |4 |15 Minutes |Presentation |Characteristics of SOPs | |5 |35 Minutes |Presentation |General Formats for SOPs | |6 | |Small group |Writing SOPs | | |20 minutes |discussion | | | | |Presentation | | |7 |05 minutes |Presentation |Key Points | |8 |05 minutes |Presentation |Evaluation | |9 |05 minutes |Presentation |Development of SOP | | | |Take home | | | | |assignment | | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Meaning of Standard Operating Procedure (SOP) (20 minutes) • Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization • It is a set of compulsory instructions, systems, procedures or steps which is written so that other individuals can follow to complete the job safely and ensure quality • SOP maximizes operational and production requirements • The purpose of a SOP is to carry out the operations correctly and always in the same manner • SOP should be available at the place where the work is performed (original copies are securely kept) • There are two main types of SOPs o Technical SOP ▪ This focuses more on technical activities such as how to weigh pharmaceutical powders on dispensing balance or how to clean a tablet press o Administrative SOP ▪ This type focuses on administrative processes such as reviewing contract documentation and determining organizational training needs STEP 3: Importances of SOPs (10 minutes) • Standard Operating Procedures are integral part of all pharmaceutical industries • To obtain a standard quality product intended for human use, the manufactured product must have undergone through current Good Manufacturing Practices (cGMP) rules and regulations • SOPs are part of cGMP and Good Documentation Practices (GDP) • An SOP guides any process, procedure or activity being performed in the pharmaceutical plant • SOPs minimizes variation and promotes quality through consistent of a process or procedure even in cases of personnel changes • SOP can be used as part of personnel on-job training as it offers instruction on how to a job • SOPs minimizes opportunities for miscommunication and can address safety concerns • A typical pharmaceutical industry has an average of 1200 to 1300 SOPs o The guide on writing all these SOPs are provided by the Mother SOP (the SOP on SOPs) STEP 4: Characteristics of SOPs (15 minutes) • SOPs have a format and length that depends on the steps that are taken to describe the procedure of the work o An SOP can be a simple one page hierarchical steps, graphic procedures or a flow chart • SOP can be written by individuals or team performing processes such as operating a tumbler mixer or cleaning of an equipment • SOPs are written by subject expert considering the GMP working feasibility, accountability and authorized by authorized persons • The SOP is meant for people who will perform a particular job • The SOP should be written before the job is began • SOP should be tested (and revised as needed) before putting it into final application • SOP should be revised when there is any change to the process or equipment used • SOP should be re-written when new information indicate new process or performance • SOP should be updated regularly depending on internal and external factors STEP 5: General Format of SOPs (35 minutes) • Various formats exist for preparation of SOP • All Standard Operating Procedures shall be written in a certain format specified in the mother SOP (SOP on SOPs) • Choice of a format depends on the organization and type of activity for which the SOP is prepared • Generally, a technical SOP consists of the following components o Title Page ▪ This is the first page or cover page of the SOP ▪ This part contains the following information ▪ Title (which clearly identifies the activity or procedure) ▪ SOP identification number ▪ Supersedes (number of previous SOP on which the current one is based or reviews) ▪ Date of issue and/or revision ▪ Name of the organization or company ▪ Department to which the SOP applies ▪ Signatures of individuals who prepared the SOP ▪ Signatures of individuals who approved the SOP o Table of Contents ▪ Needed for quick reference, especially if the SOP is long ▪ It is also needed for locating information and to denote changes or revision made only in certain sections of an SOP o Purpose/Objective ▪ This describes the purpose of the work or process including any regulatory information or standards that are appropriate to the SOP o Scope ▪ This indicates what is covered e.g. this procedure is applicable to all operation of this company (company

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06103 Pharmaceutical Production

Environmental Impact Assessment (EIA) – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103 Environmental Impact Assessment (EIA) Pharmaceutical Production • Source Session/Topic 3 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 3: Environmental Impact Assessment (EIA) Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Describe environmental management in Tanzania • Define environmental impact assessment • List key features and elements of environment impact assessment • Explain the importance of environmental impact assessment • List stakeholders of environmental impact assessment • Outline the steps in conducting environmental impact assessment Resources Needed • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer • Handout 3.1: Steps to Conduct Environmental Impact Assessment SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |15 minutes |Presentation |Environment management in Tanzania | |3 |15 minutes |Presentation |Environmental Impact Assessment | |4 |20 minutes |Presentation |Features and Key Elements of an | | | | |Effective EIA | |5 |10 minutes |Brainstorming |Stakeholders in EIA | | | |Presentation | | |6 |10 minutes |Buzzing |Importance of EIA | | | |Presentation | | |7 |35 Minutes |Presentation |Steps to Conduct EIA | |8 |05 minutes |Presentation |Key Points | |9 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Environment Management in Tanzania (15 minutes) • Management of environment in Tanzania is carried out by the National Environment Management Council (NEMC) which came into being in 1983 when the Government of Tanzania enacted the National Environment Management Act No. 19 of 1983 • NEMC was established with a broad mandate in response to the national need for such an institution to oversee environmental management issues and also implement the resolutions of the Stockholm conference (1972), which called upon all nations to establish and strengthen national environmental Councils to advise governments and the international community on environmental issues • The Environmental Management (EMA) Act No. 20 of 2004 provides for a legal and institutional framework for sustainable management of the environment, prevention and control pollution, waste management, environmental quality standards, public participation, environmental compliance and enforcement • EMA also gives NEMC mandates to undertake enforcement, compliance , review and monitoring of environmental impacts assessments, research, facilitate public participation in environmental decision-making, raise environmental awareness and collect and disseminate environmental information • Some of the objectives of NEMC are; o To enforce and ensure compliance of the national environmental quality standards. o To review of Environmental Impact Statements (EIS) and conduct environmental monitoring and auditing of projects and facilities o To undertake and co-ordinate research, investigation and surveys in the field of environment and collect, and disseminate information o To carry-out research and surveys for the proper management and conservation of environment o To render advise and technical support to entities engaged in natural resources and environmental management o To initiate and evolve procedures and safeguards for the prevention of accidents which may cause environmental degradation o To enhance environmental education and public awareness; and establish and operate national environmental information system for sound environmental management o To publish and disseminate manuals, codes and guidelines relating to environmental management and prevention or abatement of environmental degradation o To issue restoration and recommend for easements orders, and save prohibition notice STEP 3: Environment Impact Assessment –EIA (15 minutes) • Environmental Impact Assessment (EIA) is a process of evaluating the likely environmental impacts of a proposed project or development, taking into account inter-related socio-economic, cultural and human-health impacts, both beneficial and adverse • EIA is a national instrument that is undertaken for proposed activities that are likely to have a significant adverse impact on the environment and are subject to a decision of a competent national authority • EIA is used to improve decision-making and ensure that development options under consideration are environmentally, socially and economically sound and sustainable • EIA is concerned with identifying, predicting and evaluating the foreseeable impacts, both beneficial and adverse, of proposed development projects and alternatives • EIA aims to eliminate or minimise negative impacts and optimise positive impacts through mitigation and enhancement measures • EIA relates to a process rather than a particular activity, t 0he environmental impact study itself being only one component of the process STEP 4: Features and Key Elements of an Effective EIA (20 minutes) • EIA is a continuous and integral component of planning that should run continuously throughout the planning cycle of any development initiative • EIA facilitates dialogue, prediction and response and provides a forum for proponents, decision-makers and the public, to consider the potential impacts of a project on local communities, natural resources and environmental quality • EIA helps to enhance social and economic opportunities, and to promote conservation and provides a mechanism for enhancing new economic and social opportunities and for introducing long-term environmental protection and conservation measures into project design • EIA provides a framework for stakeholder participation in decision- making, experience has shown that development projects imposed on local communities often fail to address issues of local concern and priority, and hence fail to engender a perception of local ownership • EIA is a tool to improve decision-making, and provides project-specific and strategic information before project implementation decisions are reached o It is also a mechanism for addressing cross-sectoral and cross- boundary issues o EIA helps to avoid inadvertent( Unplanned) problems and their associated costs during project design • The key elements of effective EIA system o A legal basis with accompanying regulations o Appropriate institutional arrangements for co-ordination and regulation of EIA system, e.g. by an environment agency

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06103 Pharmaceutical Production

Registration and Regulation of Pharmaceutical Manufacturing in Tanzania – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103 Registration and Regulation of Pharmaceutical Manufacturing in Tanzania Pharmaceutical Production • Source Session/Topic 2 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 2: Registration and Regulation of Pharmaceutical Manufacturing in Tanzania Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain the registration of businesses in Tanzania • Explain the role of Tanzania investment centre in promoting pharmaceutical manufacturing • Outline the licensing of businesses in Tanzania • Explain the role of TFDA in establishing and regulating manufacturing of pharmaceuticals • Explain the role of TRA pharmaceutical manufacturing Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |25 minutes |Buzzing |Company Registration | | | |Presentation | | |3 |20 minutes |Presentation |Investment Approval | |4 |20 Minutes |Presentation |Business Licensing | |5 | |Small group |Medicine Manufacturing Licence | | |30 Minutes |discussion | | | | |Presentation | | |6 |10 minutes |Presentation |Taxes in Pharmaceutical Manufacturing| |7 |05 minutes |Presentation |Key Points | |8 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Company Registration (25 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |How are companies or businesses registered in Tanzania? | | | |ALLOW few pairs to respond and let other pairs to add on points not | |mentioned | | | |WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | • In order to do business in Tanzania, a business entity in form of a sole proprietorship, partnership or limited liability company needs to be formed • The business entity in form of sole proprietorship, partnership must be registered with the Business Registration and Licensing Agency (BRELA) which is under the Ministry of Industries and Trade • The first step in registration of the business name is to obtain name clearance from BRELA • Generally, the following documents are required for in the process of forming a company; o Name of the company o The address of the company in Tanzania o Names, residential addresses and nationalities of the first subscribers and directors (at least two) o Memorandum of Association (stating in details the objects of the company) and Articles of Association (stating in details the management structure and processes) ▪ At least two copies of the documents each documents are required o Filling a prescribed form to declare that a company has complied with the requirements of the Tanzania company law, and o Payment of filing fees, registration fee and the stamp duty • A certificate of registration (for sole proprietorship and partnership) or Incorporation (for a limited company) is issued after completion of the registration process • After registering the name of the company, Tax Identification Number (TIN) should be obtained from Tanzania Revenue Authority (TRA) STEP 3: Investment Approval (20 minutes) • In order to make investment incentives from Tanzania Investment Centre (TIC), the following documents are required; o Project’s business plan/feasibility study ▪ Intended project should aim at foreign exchange generation and savings, import substitution, creation of employment opportunities, linkage benefits, transfer of technology, expansion of production of goods and services etc. ▪ The feasibility study should contain clear statement of the project objective, information regarding the investor, details of investments costs (foreign and local expected capital expenditure), how the proposed investment will be financed, specific sources(s) of finance for the project, terms and condition of loans if applicable, sources of technology if applicable, project financial and economic analysis, market study, project capacity, production process if applicable, environmental impact assessment, expected employment generation, proposed implementation schedule, etc. o Filled application form from issued by TIC o In case of expansion/rehabilitation, a copy of audited account for the past three years o A copy of the company’s Memorandum and Articles of Association o Certified copy of the Certificate of company incorporation o A brief profile of the investor(s) o Evidence of sufficient financial capital available to implement the project o Evidence of land ownership for the location of the project o Project implementation schedule, and o An overall covering letter to which all the above are attached • The role of TIC in promoting investment in pharmaceutical industry are; o Aftercare service ▪ This is a core functional unit in investment promotion and facilitation whose role to facilitate both the successful start-up and continuing development of the investment with a view towards maximizing its contribution to the local economic development ▪ Aftercare unit offers assistance in ensuring that the investment project is implemented free of unnecessary obstacles o Access to various services related to permits, licenses and approvals in the TIC One Stop Facilitation Centre ▪ Companies Registration (BRELA) for registration of company ▪ Tanzania Revenue Authority (TRA) for issues related to taxes ▪ National Environment Council (NEMC) for environmental impact assessment ▪ Tanzania Foods and Drugs Authority for licensing in manufacturing of pharmaceutical products ▪ Tanzania Electric Supply Company (TANESCO) for electric power supply ▪ IOccupational Health and Safety Authority (OSHA) for issues related to occupational health ▪ Facilitates the process of obtaining work permit, resident permit, business license and land acquisition o Issuance of Certificate of incentives to investors ▪ Incentives offered; ▪ The recognition of private property and protection against any non-commercial risks. Tanzania is an active member of the World Bank

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06103 Pharmaceutical Production

Introduction to Pharmaceutical Production – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103 Introduction to Pharmaceutical Production Pharmaceutical Production • Source Session/Topic 1 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 1: Introduction to Pharmaceutical Production Total Session Time: 60 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Define terminologies used in pharmaceutical production • List the general requirements for pharmaceutical production • Outline products manufactured in Pharmaceutical Productions Resources Needed • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |25 minutes |Buzzing |Definitions | | | |Presentation | | |3 |10 minutes |Presentation |Requirements for Pharmaceutical | | | | |Production | |4 |10 minutes |Buzzing |Products in Pharmaceutical | | | |Presentation |Productions | |5 |05 minutes |Presentation |Key Points | |6 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Definitions (25 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |Define Good Manufacturing Practices | | | |ALLOW few pairs to respond and let other pairs to add on points not | |mentioned | | | |WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | • Pharmaceutical production (pharmaceutical manufacturing) o This is the process of industrial (large) scale synthesis of pharmaceutical drugs by pharmaceutical companies • Batch, batch size an batch number o A batch is a quantity or consignment of pharmaceutical products produced in a single manufacturing run o The total number of items in one batch is the batch size o Each batch is given a specific identification code called the batch number • Batch production o This is a technique used in manufacturing, in which the object in question is created stage by stage over a series of workstations, and different batches of products are made • Batch Manufacturing Record (BMR) o A batch manufacturing record is a document designed to provide a complete record of the manufacturing history of a batch of product o BMR is also known as; ▪ BPR-Batch processing record ▪ BPCR-Batch processing and control record • Master Formula Record o A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of the product as well as the processing instructions including the in-process controls o There are must be a master formula record for each product and batch size to be manufactured • Mixing is a process whereby different ingredients are put together to form a mixture • Weighing and Measuring o Weighing is a process of determining weight of ingredients (for example by using a weighing balance) o Measuring is the determination of volume of liquid ingredients by using graduated measures such as measuring cylinders, pipettes etc. • Tableting o This is a process of compressing powders or granules to form tablets • Tablet Press o This is an equipment that is used for manufacturing of tablets • Encapsulation o This is a process of enclosing powders, tablets, pellets, granules or liquids in shells commonly made up of gelatin to form capsules • Quality Assurance (QA) o It is a wide ranging concept covering all matters that individually or collectively influence the quality of a product • Good Manufacturing Practices (GMP) o GMP is a part of quality assurance (which sets out principles and procedures) that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use • Quality Control (QC) o It is part of GMP concerned with sampling, specifications and testing and with the organization, documentation and release procedures which ensure that the necessary the necessary and relevant tests are carried out and the materials are neither released for use nor products are used for sale or supply until their quality has been satisfactory • Active Pharmaceutical Ingredient (API) “Drug substance” o An ingredient which gives a drug its chief therapeutic value; i.e. responsible for pharmacological action. OR o Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in production of a drug, becomes an active ingredient of that drug. • Drug o Any chemical compound used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiologic or pathologic state. OR o Medicine, pharmaceutical substance which when absorbed into a living organism may modify one or more of its functions. • Drug Product o A unique combination of drug(s), strength and dosage form in which a drug is administered. • Finished Pharmaceutical Product o A medicinal product/dosage form which has undergone all stages of manufacture or production, including packaging in its final container and labeling. • Pharmaceutical Dosage form: o Is the form in which drugs are formulated and ready for delivery to the patients. E.g. solution, mixture, emulsion, suspension, injectable, tablets, capsules etc • Excipients or Additives or adjutants. o A chemical substance/additive with no pharmacological action, used in the formulation of dosage forms. Vehicle for the drug. o A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to: ▪ aid in the processing of the drug

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06102 Counselling and Guidance

Compliance in Treatment – PST06102 Counselling and Guidance

NTA Level 6 • Semester 1 • PST06102 Compliance in Treatment Counselling and Guidance • Source Session/Topic 15 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. PST 06102 : Counselling and Guidance Session 15 : Compliance in the Treatment 1 Learning tasks At the end of this session, students are expected to be able to : Give introduction to compliance in the treatment Describe importance of compliance in treatment Explain reasons for non-compliance in the treatment Explain methods of improving compliance Explain methods of assessing compliance 2 Activity: Buzzing What is compliance in the treatment ? 3 Compliance in Treatment Is filling up and complete an action or process and fulfilling the promise to a desirable, requested conditions specific to act in conformity. Compliance can mean ‘accord agreement of amicable relations that has conformity. Poor compliance to treatment of chronic diseases is a worldwide problem of striking magnitude., average of 50% in most diseases and excessive non-compliance accounts for a significant percent of admissions in patients with heart failure 4 The consequences of poor compliance to long-term therapies are poor health outcomes and increased health care costs, Increasing the effectiveness of compliance interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments, a multidisciplinary approach towards compliance is needed 5 Types of patients based on the acceptance of diagnosis and treatment initiation, patients are categorized into four types Non compliers : those who do not accept diagnosis and need treatment. Partial compliers : those who accept diagnosis and treatment but cannot fulfill the recommended actions sufficiently to reach targeted improvements in their health. Over compliers : those who take recommended actions in excess of targeted improvements (these patients are rare). Adequate compliers : those who follow health advice adequately to improve or control their disorder 6 Importance of Compliance in Treatment Taking your medicine as prescribed or medication adherence is important for controlling chronic conditions, treating temporary conditions, and overall long-term health and well-being. A personal connection with your health-care provider or pharmaceutical personnel is an important part of medication compliance 7 F actors determined to have the most important effect on patient compliance with dispensed medications Understanding of medical directions Involvement in the Process Compliance reminders 8 Activity: Buzzing What are the reasons for non-compliance in the treatment? 9 Non-compliance in the Treatment Non-compliance, failure or refusal to comply, in medicine, the term non-compliance is commonly used in regard to a patient who does not take a prescribed medication or follow a prescribed course of treatment A person who demonstrates non-compliance is said to be non-compliant 10 Reasons for Non-compliance in the Treatment a. The nature of patient’s illness: Patients suffering from schizophrenia has high incidence of non-compliance, due to distorted reality & lack of insight do not recognize their illness and need for treatment, similarly in chronic disorders like hypertension, tuberculosis etc b. Therapeutic regime: Multiple drug therapy like 5-6 prescribed drugs taking at different timings ,taking tablets with same color, size and shape cause more confusion and skip doses also technical difficulty in using inhalers 11 c. Duration of treatment: Compliance is inversely proportional to duration of treatment, in a long term therapy, low compliance is observed as in bronchial asthma and hypertension d. Frequency : Increased frequency of drug administration causes more disruption of normal routine or work schedule, hence many patients forget or inconvenienced or embarrassed 12 E. Adverse events, Some patients are non-compliant due to adverse events. Some drugs like Anti-Hypertensive agents, Anti depressants or Anti psychotics cause sexual dysfunction which is frequently implicated for non compliance F. Taste of medication , Can be the cause for noncompliance especially in children. Failure to comprehend the importance of therapy, as patient has limited knowledge about the illness, become non compliant if beliefs and expectations are not met with, poor understanding of instructions also contributes to non compliance 13 G . Taste of medication, Can be the cause for noncompliance especially in children. Failure to comprehend the importance of therapy, as patient has limited knowledge about the illness, become non compliant if beliefs and expectations are not met with, poor understanding of instructions also contributes to non compliance 14 Other Non compliance to treatment Increased , or decreased sensitivity to drugs, Frequent change of prescriptions( prescription cascade), Living alone, Lack of social support system, Difficulty in opening the medication container that has flip off type of lid Going to pharmacist/chemist due to physical problems like (osteoarthritis) Cognitive impairment, Impaired mobility or dexterity, Swallowing problems, Financial issues like, Low income and high cost of medications, Everyday inconvenience in carrying and taking of medicines 15 Methods of Improving Compliance I nclude health education to increase retention of the regimen, self-monitoring of medication habits, tailoring medication taking to other daily habits and treatment contracts 16 O ther methods The patient can be supervised while taking the drug for example, during treatment in hospital, by parents giving medicines to their children, visitors giving drugs to relatives, and a district pharmaceutical personnel giving medicines to elderly people Single dose treatment eg syphilis, Improving the palatability of medicines by flavouring medicines for children Blister calendar packs for oral contraceptives or better blockers help p to remember to take the drug . 17 By simplifying therapeutic regimens, reducing the number of tablets and reducing the frequency of administration.. By educating the patient, patient education on the nature of their condition and the necessity and aims of treatment 18 Methods of Assessing Compliance Tablet counting Recording devices Measuring the concentration of the drug in body fluids Measuring the pharmacological effect Measuring a marker substance added to the drug 19 Key points Compliance: Is filing up and complete an action or process and fulfilling the promise to a desirable, requested conditions specific to act in conformity, Methods to improve compliance to medication include health education

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06102 Counselling and Guidance

Adherence in Treatment – PST06102 Counselling and Guidance

NTA Level 6 • Semester 1 • PST06102 Adherence in Treatment Counselling and Guidance • Source Session/Topic 14 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. PST 06102 : Counselling and Guidance Session 14: Adherence in the Treatment 1 Learning tasks At the end of this session, students are expected to be able to : Give Introduction to adherence in the treatment Describe difference between adherence, compliance and concordance in the treatment Describe importance of adherence in the treatment Explain reasons for non-adherence in the treatment Explain methods of improving adherence in the treatment 2 Activity: Buzzing What is adherence in the treatment? 3 Adherence in the treatment Adherence: is defined as the extent to which a patient takes medication in the way intended by a health care provider, This is include, patients taking all medications at the correct time, in the appropriate quantities and in line with additional instructions regarding food or drug interactions Medicines play an important role in medical care and effectiveness of treatment depends on both the efficacy of medication and patient adherence to the therapeutic regimen. 4 Adherence in the treatment …. Adherence to medication is essential to achieve the best possible pharmacotherapy outcomes. Evidence shows that non-adherence medications result in higher health care costs, longer hospitalization, and increased morbidity and mortality. 5 Adherence in the treatment … A medication is the most frequent intervention within healthcare systems worldwide. Achieving the best possible outcome of medication for the quality of life of patients should be the primary aim of all health professionals involved in the medication process, as well as carers and patients, depending on their abilities and capacities Adherence is a major issue for long term medication in chronic diseases, between 1/3 to ½ of medicines prescribed are not taken as intended, this affects: Patients’ health leading to decreased quality of life, complications, preventable hospitals admissions and mortality/morbidity 6 Adherence in the treatment …. Non-adherence in the society increased healthcare cost/government spending, untreated diseases expose the society to potential problems such as infectious diseases like TB/HIV, psychiatric diseases e.t.c Medication non adherence can be divided into four categories: Primary non adherence Secondary non adherence Unintentional non adherence Intentional non adherence 7 1. Primary non adherence : is when a patient does not fill an initial prescription; 2. Secondary non adherence : is when a patient does not refill a prescription on time. 3. non adherence : occurs when a patient simply forgets to take medication or is careless in some way as to miss a scheduled dose; 4. Intentional non adherence : is a decision of not taking the medication, and may be the most important aspect of non adherence that must be addressed, with some estimates showing that up to 80 percent of non adherence may be intentional 8 Differences between adherence, compliance and concordance In contrast, compliance and adherence relate to the medicine-taking behavior of the patient. Compliance and adherence can be estimated using prescription claims records, pharmacy dispensing data, validated survey instruments or electric pill counters, as well as direct measures such as serum drug levels However, the definition of concordance implied that the prescriber and patient should come to an agreement about the regimen that the patient will take 9 10 Important of Adherence in the Treatment Treatment adherence is generally regarded as an important factor in achieving optimal outcomes across many disease states. In the treatment of chronic disease like HIV, Cancer and tuberculosis, poor adherence to treatment has the potential to impact outcomes on multiple levels. The health system in where pharmaceutical personnel practices is integral to achieving the ultimate goal of improved patient health, because medication adherence is an important contributor to improved patient health, health care systems must evolve in a way that emphasizes its importance. 11 Therefore the importance of adherence in the treatment are: To decrease morbidity and mortality in the community and reduce health cost Help to improve effectiveness of medicines Strengthen relationship between patients and health workers Lessening number of hospitalities 12 Reasons for Non-adherence in the Treatment Medication non-adherence is a serious problem with possible life-threatening consequences. Patients frequently are unable to recognize their own adherence issues, especially for chronic medications Reasons for non-adherence to prescribed medicines are commonly divided into 5 intersecting categories; Patient variables. Treatment regimen. Disease characteristics. Patient provider relationship. Clinic setting 13 Patient Variables Sociodemographic factors i.e . age, gender, race/ethnicity, income, education, literacy, housing status, insurance status Psychosocial factors i.e . mental health, substance use, social climate and support, knowledge and attitudes about disease and its treatment. Common predictors of non-adherence include depression/psychiatric morbidity, active drug or alcohol use, stressful life events, lack of social support, and the inability to correctly identify the drug regimen or describe the relationship between adherence and drug resistance . 14 Treatment Regimen Factors related to the treatment regimen include: The number of pills prescribed, the complexity of the regimen ie . dosing frequency and food instructions, the specific type of medicines dispensed, the short- and long-term medication side effects. The complexity of the regimen and side effects caused by it are clearly associated with non-adherence, the impact of once-daily regimens on adherence behavior, amid great hope for a beneficial effect 15 Disease Characteristics Disease characteristics include the stage and duration of infection, associated opportunistic infections, and disease-related symptoms, there is a relationship between disease-related symptoms and non-adherence. 16 Patient-Provider Relationship Patient-provider relationship characteristics that may affect adherence include; The patient's overall satisfaction and trust in the provider and clinic staff, the patient's opinion of the provider's competence, the provider's willingness to include the patient in the decision-making processes The affective tone of the relationship ie . Warmth, openness and cooperation, the concordance of race/ethnicity between patient and provider and the adequacy of referrals . 17 Patient-Provider Relationship May affect adherence include; The patient's overall satisfaction and trust in the provider

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06102 Counselling and Guidance

Co-ordination of Health Workers at CTC – PST06102 Counselling and Guidance

NTA Level 6 • Semester 1 • PST06102 Co-ordination of Health Workers at CTC Counselling and Guidance • Source Session/Topic 13 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. PST 06102 : Counselling and Guidance Session 13: Co-ordination of Health Workers at CTC 1 Learning tasks At the end of this session, students are expected to be able to : Explain concept of the co-ordination of health workers at CTC Identify services provided by staff within CTC Explain impact of health care workers on HIV and AIDS Programmes at CTC 2 Concept of the Co-ordination of Health Workers at CTC Caring for HIV/AIDS patients requires health care workers (HCWs) to have good knowledge of the issues, cultural differences in HCWs, combined with professional ethics and personal beliefs, could also result in conflicting attitudes, leading to difficulties related to looking after people affected by HIV/AIDS For CTC services to function well, adequate and trained staff need to have clearly outlined roles and responsibilities, since HIV and AIDS is now a manageable chronic disease, the principles of chronic disease management must be followed. 3 Team approaches involving a patient, a family care giver and a healthcare team i.e. consisting of at least a triage nurse, a doctor and a treatment/adherence pharmaceutical personnel to ensure the building of an ongoing relationship between patient and the health care team for life-long care. Regularly scheduled visits minimize drug depletion at home; this is enabled by records that are easy to retrieve, and disciplined observance of appointment schedules. 4 Weekly CTC team meetings to discuss bottlenecks and case studies will help to build team spirit, while quarterly staff meetings between heads of relevant units involved in HIV care such as CTC, TB, VCT, PRCH, STI, HBC, Pharmacy, Laboratory and In-patient units will help to build better internal cooperation and patient referrals . Council Health Management Team (CHMT) members must conduct regular at least quarterly supportive supervision visits to assess efficiency and effectiveness of service delivery, and identify where mentoring by experts from supervising hospitals or health programmes should be put in place. 5 Activity: Buzzing What are the services provided by staff within CTC? 6 The National Standard Operating Procedures manual outlines the following services to be provided by available staff within CTC: Registration and appointments management; filling of CTC1 and CTC2 basic information; height, weight, Blood Pressure (BP), (Body Mass Index(BMI)), pulse rate and temperature Triage: assessment of immediate medical needs, TB screening questionnaire, support and referring the patient to the next relevant unit or staff at the CTC 7 Clinical management Patient ART preparedness and adherence counselling All elements of PHDP Data collection and management Referral management within the hospital, and with relevant institutions and community organizations 8 9 Impact of Health Care Workers on HIV and AIDS Programmesat CTC HIV and AIDS programmes have had a direct impact on health care workers (HCW) at CTC into; Recruitment of HCW at CTC Distribution and retention of HCW at CTC; Attrition of HCW at CTC 10 a. Recruitment of health workers at CTC Recruitment in this context includes all measures and processes used to prepare and deploy HCWs into the HIV and AIDS programmes; for instance, HCW like doctors, pharmaceutical personnel, nurses etc who shifted from their normal activities to HIV and AIDS programmes, they must effectively recruited into HIV and AIDS care. HIV and AIDS programmes create greater demand for HCWs, in response to which there have been efforts to recruit additional staff, including new cadres, the additional staff may be from the existing stock of HCWs, or could be from outside the system, depending on the country involved . 11 b . Distribution and retention of HCW at CTC; Exploring impact, opportunity and lessons from, HIV/AIDS service programmes on HCW distribution and retention There is specific HCW retention strategies including financial and non-financial incentives, in scale up for HIV and AIDS services Specific workplace challenges and wider issues in retaining health workers in the context of HIV/AIDS at CTCs especially in high burden countries are solved 12 Health worker get HIV/AIDS treatment and prevention programmes including infection prevention and control measure (IPC) and post exposure prophylaxis (PEP) HIV and AIDS drive deployment policies skills mix, task shifting and their relationship to the rest of the health system to improve distribution and retention HCW 13 c. Attrition of health workers at CTC Employment impact opportunity and lessons from, HIV and AIDS programme on HCW resignation, illness ,absenteeism, premature retirement, death and emigration all cause Attrition of health care workers at CTC AIDS/HIV treatment and prevention programme to HCW mitigate attrition of health care workers at CTC 14 Strategies to address higher demand for HIV and AIDS services resulting stress, frustration, burn-out hence there is a need to mitigate attrition of HCW HIV and AIDS driven improvement in working conditions and how they mitigate HCW attrition 15 Key points For CTC services to function well, adequate and trained staff, need to have clearly outlined roles and responsibilities, since HIV and AIDS is now a manageable chronic disease, the principles of chronic disease management must be followed. The National Standard Operating Procedures manual outlines the different services to be provided by available staff within CTC 16 Review questions What are the services provided by health workers at CTC? What are the impacts of health workers on HIV/AIDS programme ? 17 References Essengue M-S (2003) ‘ Assessment of human resources for scaling up HIV/AIDS/ART country programmes, ’ Duty travel report from site visits in Rwanda. Geneva: WHO, Department of Human Resources for Health. MOHSW (2009). Provider Initiated HIV Testing and Counselling: Trainer’s Manual. Dares Salaam, Tanzania: National AIDS Control Programme . Uebel KE, Nash J and Avalos A (2007) ‘ Caring for the Caregivers: Models of HIV/AIDS Care and Treatment Provision for Health Care Workers in Southern Africa,’ Journal of Infectious Diseases 196 (Supplement) : UNAIDS (2007)

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06102 Counselling and Guidance

Pharmaceutical Personnel at CTC – PST06102 Counselling and Guidance

NTA Level 6 • Semester 1 • PST06102 Pharmaceutical Personnel at CTC Counselling and Guidance • Source Session/Topic 12 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. PST 06102 : Counselling and Guidance Session 12 : Pharmaceutical Personnel at CTC 1 Learning tasks By the end of this session students are expected to be able to: Explain concept of the role of pharmaceutical personnel at CTC List role of pharmaceutical personnel at CTC Explain role of pharmaceutical personnel at CTC Identify Steps for providing counselling and guidance to patients at CTC for medicinal use 2 Concept of the Role of Pharmaceutical Personnel at CTC Patient counseling and guidance about medications at CTC; involve providing medication information orally or in written form to the patients or their representative or providing proper directions of use, advice on side effects, storage, diet and life style modifications, it involves a one-to-one interaction between a pharmaceutical personnel and a patient or care giver. Pharmaceutical personnel and patient need to come to a common understanding about their respective roles and responsibilities. It may be necessary to clarify for patients that Pharmaceutical personnel have an appropriate and important role in providing education and counselling and patients should be encouraged to be active participants. Pharmaceutical personnel provide optimal management of medication for chronic diseases such as diabetes, asthma, hypertension, HIV/AIDS etc. The collaboration of healthcare professionals , such as physicians and Pharmaceutical personnel, can help to ensure that patients properly take their medications as prescribed and avoid any harmful effects 3 In addition to a current knowledge of pharmacotherapy, Pharmaceutical personnel need to have the knowledge and skills to provide Effective and accurate patient education and counseling. They should know about patients‘ cultures, especially health and illness beliefs, attitudes , and practices. They should be aware of patients‘ feelings toward the health system and views of their own roles and responsibilities for decision-making and for managing their care. 4 What are the roles of pharmaceutical personnel at CTC? 5 Role of Pharmaceutical Personnel at CTC Role of pharmaceutical personnel in the management of HIV/AIDS and related problems in the CTC are: Selecting and reviewing therapy i.e. general principles, resistance to antiretroviral drug , management of drug interaction, complementary or alternative medicines, general promotion and maintenance of health Tailoring treatment for specific populations i.e. women, pediatric patients, patients with comorbidity, patients with co-infections with hepatitis virus, marginalized patients groups, immigration and indigent population Counselling patients i.e. counseling and educating on adherence issues. Monitoring response to therapy i.e. managing adverse drug reaction and therapeutic drug monitoring and professional networking and collaborations 6 Role of Pharmaceutical Personnel at CTC 1. Selecting and reviewing therapy, General principles Pharmaceutical personnel working at CTC should be familiar with current treatment principles so that they can effectively manage and optimize pharmacotherapy for HIV infected individuals, they should also be familiar with recommendations on prophylaxis and treatment of opportunistic infections that occur in conjunction with HIV infection Resistance to Antiretroviral Drugs Resistance to antiretroviral is a major cause of treatment failure, it is therefore important for pharmaceutical personnel to understand the mechanisms of and factors contributing to development of drug resistance. 7 Pharmaceutical personnel at CTC can play an important role in preventing the development of drug resistance by ensuring selection of potent antiretroviral regimens; monitoring and reinforcing the need for strict adherence; screening for and managing drug–drug interactions; anticipating and effectively managing adverse effects, as a means to increase adherence ; providing appropriate education about the relationship between nonadherence and development of resistance aggressively managing treatment failure by switching therapy to prevent further accumulation of resistance mutations 8 Management of Drug Interactions Patients are now living longer and experiencing co-morbidities such as cardiovascular disease , hyperlipidemia, hypertension, diabetes mellitus, gastrointestinal conditions, osteoporosis , renal disease, and non–AIDS-related cancers, which may be manifestations of long-term toxic effects of the antiretroviral, increasing age, or the virus itself. Pharmaceutical personnel should be aware of the types and mechanisms of drug interactions if they are to manage such interactions effectively Interactions between antiretroviral and other drug classes have not been exhaustively elucidated , so pharmaceutical personnel at CTC need to be aware of the pharmacological and pharmacokinetic characteristics of specific agents to identify or predict potential drug interactions 9 Management of Drug Interactions Pharmaceutical personnel at CTC must utilize current sources of information to make an accurate assessment, in situations of suspected or potential drug interactions, close clinical, virological , and therapeutic drug monitoring is necessary. In some instances, dose adjustments may be beneficial in optimizing the clinical response, including viral suppression, other management options include altering dosing frequency or replacing one agent with another drug that has lower potential for interaction 10 Pharmaceutical Management cycle 11 Complementary or Alternative Medicine The concomitant use of CAM with antiretroviral is common, patients need to be reminded that , in contrast to conventional medications, the large majority of CAM products are not licensed and are not required to meet the standards for efficacy, safety, bioavailability, and stability that are required for conventional medications before they can be marketed, Herbal remedies are classified as dietary supplements, and manufacturers do not have to prove the safety and effectiveness of dietary supplements before marketing them. Pharmaceutical personnel can play a crucial role by providing reliable information about CAM to help patients who visit at CTC to understand the potential risks, benefits, and uncertainties regarding specific products of interest. When indicated, potential interventions include offering therapeutic alternatives, evaluating the risk of drug interactions, recommending therapeutic drug monitoring, and ensuring optimal adherence with combination antiretroviral therapy 12 General Promotion and Maintenance of Health With the evolution of HIV infection into a chronic manageable disease, patients who are receiving stable combination antiretroviral therapy may be seen less frequently. Pharmaceutical personnel, especially those practicing in ambulatory or community settings, can play a significant role in this aspect of

Pharmaceutical Sciences Notes, PST Level 6 Semester 1, PST NTA Level 6, PST06102 Counselling and Guidance

Types of Counselling and Guidance at VCT and PITC – PST06102 Counselling and Guidance

NTA Level 6 • Semester 1 • PST06102 Types of Counselling and Guidance at VCT and PITC Counselling and Guidance • Source Session/Topic 11 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. PST 06102 : Counselling and Guidance Session 11 : Types of Counseling and Guidance provided at VCT , and PITC 1 Learning tasks By the end of this session students are expected to be able to: Describe HIV Testing and Counseling Approaches in Tanzania Explain pre and post test counseling Explain prevention and disclosure counseling Describe bereavement counseling 2 HIV Testing and Counseling Approaches in Tanzania Different approaches to HIV testing and counseling exist in Tanzania as follow; Client-Initiated Counseling and Testing (VCT); client voluntarily makes the decision to learn his/her HIV status and seeks for counseling and testing services out of his/her own will for the purpose of prevention of HIV infection and personal life decision making Provider-Initiated HIV Testing and Counseling (PITC); HIV testing and counseling which is recommended by health care provider to person attending Health Care Facilities as standard component of medical care 3 Activity: Buzzing What are the types of counselling and guidance provided at CTC? 4 Pre and Post Test Counseling There are several types of counseling in relation to HIV Counselling and guidance. The essence of the different types of counseling and guidance is to provide guidance and counseling in different stages of HIV infection that the infected person and the relations go through. The types include: Pre-test counselling, post-test counselling, prevention counseling, bereavement counseling and disclosure Counseling 5 Pre-test counseling Pre-test counselling simply refers to counseling given to an individual prior to taking an HIV test. It is given to prepare the person for the HIV test and the implications of taking the test. Post Test Counselling Post test counseling simply refers to counselling given to an individual after an HIV test is conducted and is given irrespective of what the HIV test result is. The main goal is to help the client to understand and come to terms with his/her test results and to initiate adaptation to their seropositive or seronegative status. 6 Prevention and Disclosure Counselling Prevention Counselling Prevention counselling is similar to pre-test counseling as it provides an opportunity for the counsellor/client to negotiate and reinforce a plan to reduce or eliminate the risk of HIV transmission . Prevention counseling can also be given to relatives and significant others of an infected person so as to protect them from contacting the infection in the process of caring for the PLWHA . 7 Prevention and Disclosure Counselling Disclosure Counselling; Disclosure of HIV status is advocated to reduce stigma among PLWHA. Clients prepared emotionally for the outcome of disclosing, they are helped to identify who the disclosure might be affect (e.g. spouse, children) and to be aware of potential negative consequences . Health workers must ensure that there is adequate support and preparation before and after disclosing PLWHA may need support to disclose their status to loved ones and their loved ones may need support to cope with their feelings about the information. 8 Bereavement counselling Bereavement counseling Bereavement is a term that can be used to describe any event that includes loss, so this could mean losing a job or the death of someone you know. Bereavement can also be termed as grief . Bereavement in relation to HIV/AIDS could be grief over the loss of a dear one or grief upon learning one or a partner or a friend is HIV positive 9 Normal Grief Reactions The normal grief reactions can include: Feelings : This can be expressed in the form of shock, anger, Sadness, guilt, self reproach , loneliness, helplessness, hopelessness, depression, numbness and feelings of unreality Physical symptoms: Such as tightness in throat and chest, excessive sensitivity to noise , irritability, weakness, loss of appetite, insomnia, weight loss. Behavior : This can be manifested in the form of confusion, hallucination (seeing or hearing the deceased person), tearfulness, Absentmindedness, obsession to belongings of deceased person, irrational behavior 10 Potential Danger Signs in Grief Reactions When someone feels he/she is no longer of value as a person Behavior or personality changes that are inconsistent with clients normally behavior pattern . When client makes threats of self-destruction Excessive hostility Complete withdrawal and unwillingness to interact with other people Appearance of fleeing from reality 11 Stages of bereavement are; Denial : first reaction that people have to the loss of a loved one or a diagnosis of HIV, tend to deny and may withdraw from usual social contacts. Anger ; There is the stage of anger at self, loved one, God, the world, the HIV virus and the world in general. Questions such as ―Why me?‖, ―Why did it happen to him/her ?‘ are asked over and over again. Bargaining; At this stage the grieving person may make bargains with God, asking, "If I do such and such, will you take away the loss?", ―I promise I'll be a better person if ….‖ Hoping that the loss will disappear or magically be made right. 12 Depression; At this stage the person feels numb, although anger and sadness may remain underneath but the person feels tired and doesn‘t care any longer about what happens . A sense of hopelessness and helplessness washes over the person and leaves him or her unable to muster energy to do anything and everyday functioning may also be a problem. Acceptance ; At this stage there is a sense of resignation, when anger, sadness and mourning have tapered off. The person simply accepts the reality of the loss and lets‘ go, but memories still remain . It is not a pleasant feeling but rather a feeling of being ready for whatever may come. 13 Key Points There are several types of counseling in relation to HIV Counselling and guidance, The essence of the different types

banner
Scroll to Top